Dr. Grant
Burch, M.D., associate professor of pediatric cardiology at OHSU Doernbecher
Children's Hospital and director of the OHSU Pediatric and Adult Congenital
Cardiac Catheterization Lab, and Laurie Armsby, M.D., Burch's partner in the
OHSU Pediatric and Adult Congenital Cardiac Catheterization Lab and associate
professor of pediatric cardiology at OHSU Doernbecher Children's Hospital, have
used adevice to implant a pulmonary
heart valve without the use of open-heart surgery.

The
device is called the Medtronic Melody Transcatheter Pulmonary Valve, and it is
used to replace a leaky or narrow pulmonary valve conduit in adults and
children that have already had surgery to fix a congenital heart defect. This
tool was recently approved by the Food and Drug Administration (FDA), and does
not require open-heart surgery. It was first approved for commercial use in Europe
in 2006, and since then, over 1,700 patients have been implanted with the
pulmonary valve. Now, according to the FDA, 1,000 U.S. citizens with congenitalheart disease will qualify for the Melody valve
each year.

"Children
born with blocked or leaky heart valves can undergo as many as four open-heart
surgeries before reaching adulthood to replace conduits that have worn out or
that they've outgrown, and each time the risk of surgery goes up," said
Burch. "The Melody extends the useful life of an implanted valve conduit
and is very likely to reduce the number of open-heart operations a patient
might require over a lifetime."

The
Melody is placed into a small opening in a patient's leg and is led by a
catheter through blood vessels into the heart. A balloon on the end of the
catheter is inflated once the valve is positioned in place, which delivers the
valve and correctsblood flow.

"The
remarkable thing about this procedure is that the valve is placed into thebeating heart through a vein in the patient's
leg," said Armsby. "After the procedure, patients spend a night on
the hospital ward and are discharged home the following morning. This device
brings us closer to the goal of providing children less invasive alternatives
to surgery for the treatment of congenital heart disease."

Burch
noted that the Melody valve cannot eliminate the need for open-heart surgery
entirely, but it can be used as a safe alternative for those with congenital
heart disease.

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